510(k) · Cleared
ClearedA&D Medical UM-212BLE Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A&D Company, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 6, 2022 as substantially equivalent to K173191 (A&D Company, Ltd., 2019) and 1 other predicate after a 451-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Oct 6, 2022
- Review
- 451 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K982481 (1998). 11 ancestors in all, the oldest K871718 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 5 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 4 generations backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- 3 generations backK082734 A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
- 2 generations backK111686 A & D Medical UA-1000 Family Dagital Blood Pressure MonitorsA&D Company, Ltd. · 2011
- 1 generation backK173191 A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019
- This deviceK212168 A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −5 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −4 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| −3 | K082734 | A&D Medical UA-851THW Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2008 | — |
| −2 | K111686 | A & D Medical UA-1000 Family Dagital Blood Pressure Monitors | A&D Company, Ltd. | 2011 | — |
| −1 | K173191 | A&D Medical Blood Pressure Monitors | A&D Company, Ltd. | 2019 | — |
| 0 (this device) | K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173191 | A&D Medical Blood Pressure MonitorsSummary page 4…DXN, DXQ 4. Information for the 510(k) Cleared Devices (Predicate Devices) • A&D Medical UM-211 Digital Blood Pressure Monitor 510(k) number K173191 • A&D Medical UA-767PBT Digital Blood Pressure Monitors with 510(k) number K043217 5. Indication… | 2019 |
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 4…edical UM-211 Digital Blood Pressure Monitor 510(k) number K173191 • A&D Medical UA-767PBT Digital Blood Pressure Monitors with 510(k) number K043217 5. Indications for Use UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and puls… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212168: A&D Medical UM-212BLE Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212168
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026